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CTRI Number  CTRI/2025/04/085870 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Diabetes Self mnagement Coaching]  
Study Design  Other 
Public Title of Study   effect of Diabetes self management coaching on glycemic control 
Scientific Title of Study   Effect of Center and Voice call based Diabetic Self Management Coaching(CV-DSMC) on clinical and behavioral outcome among elderly people with type 2 diabetes at KMCH RHTC Vagarayampalayam coimbatore India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MALARKODI M 
Designation  Professor 
Affiliation  KMCH COLLEGE OF NURSING 
Address  ROOM NO 218 Department of Community health nursing KMCH college of nursing
KMCH COLLEGE OF NURSING Phase II,balagi nagar kalapati road coimbatore
Coimbatore
TAMIL NADU
641048
India 
Phone  9361140010  
Fax    
Email  malarkodi@kmchcon.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr.S.ARUNA 
Designation  Professor & HOD 
Affiliation  Sriramachandra Insistute of Higher education and Research 
Address  Room No.115 Department of Community health nursing Sriramachandra Faculty OF NURSING,
Sriramachanda Faculty of Nursing,SRIHER(DU), Porur 600116
Chennai
TAMIL NADU
600116
India 
Phone  9444412607  
Fax    
Email  aruna.s@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  MALARKODI M 
Designation  Professor, 
Affiliation  KMCH COLLEGE OF NURSING 
Address  Room no 218 Department of Community health nursing KMCH COLLEGE OF NURSING,
KMCH COLLEGE OF NURSING,PHASE II,BALAJI NAGAR, KALAPATTY ROAD, kalapatti ,coimbatore
Coimbatore
TAMIL NADU
641048
India 
Phone  9361140010  
Fax    
Email  malarkodi@kmchcon.ac.in  
 
Source of Monetary or Material Support  
KMCH RURAL HEALTH CENTER -STUDY CENTER,VAGARAYAMPALAYAM,COIMBATORE,TAMILNDU 641659. 
 
Primary Sponsor  
Name  MALARKODI M 
Address  KMCH college of Nursing kalapatti post coimbatore-48 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrJeevithan  KMCH RURAL HEALTH CENTER  ROOM NO.10, OUT PATIENT DEPARTMENT,Vagarayampalayam, Tamil Nadu 641659
Coimbatore
TAMIL NADU 
9965570174

dr.jeevithan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMCH ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  diabetes self management education  The intervention will be delivered in two phases Phase I- Centre based Coaching Phase II- Voice call Coaching Education session, Practical Demonstration (1 hr/session- 4 weeks)-, Reinforcement-I(2 months), Reinforcement-II (2 months) 10- to 20min voice call coaching sessions will be given bimonthly for first 2 months. Monthly once voice call coaching will be given for next 2 months.  
Comparator Agent  only education session will conducted  patients will be receiving usual care and education is given.reinforcement and voice call coaching will not be provided 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients diagnosed with type 2 diabetes with a duration of 5 years
2.Patients with HbA1c more than 8
3. Aged between 60-80 years and Patients of both sex
4.Patient with symptoms of neuropathy with confirmed type 2diabetes
5.An average daily Neuropathy pain score more than4
 
 
ExclusionCriteria 
Details  1. Patients who are having Plantar ulcers and foot problems
2.Patients with hearing deficit
3.History of Orthopedics complications
4.Patients with chronic kidney disease
5.Patients with other skin disease
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
HbA1c   6month and 9 months  
 
Secondary Outcome  
Outcome  TimePoints 
compliance to treatment  9 months 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  result of the study

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 10-06-2026 and end date provided 03-02-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

INTERVENTION

Centre and Voice call based   (CV –DSMC) Diabetes Self-Management Coaching 

 The  intervention will be delivered in two phases

Phase  I- Centre based Coaching

Phase II- Voice call Coaching

 Centre based coaching  is categorized into 2 types :1) Educational, which refers to interventions in which patients with diabetes mellitus primarily receive information from the researcher, focusing on the provision of information to improve patients’ knowledge of diabetes self-management.Face to face  education will be imparted by the researcher through a prerecorded laptop assisted lecture and discussion method using visual aids like charts and pamphlet  in group sessions of four hours, split in to four  teaching sessions of 30 minutes each. A total of 20 groups with 6 to 7 patients in each group  will be grouped for the education sessions. The content of the education includes diabetes mellitus, short term and life-threatening complications of diabetes, long term concerns, other health issues of diabetes mellitus, principles of diabetes management self-care in diabetes mellitus, planning diet and the way forward.

Educational  intervention total 2 hrs( 1/2 hr/session- 4 weeks)

2) Behavioral, which refers to the interventions targeting improved self-management behaviors, with a focus on active skills training and emphasizing change in skills and/or lifestyle associated with the implementation of a diabetes self-management regimen, such as diet, physical activity, blood glucose monitoring, adherence to medication and application of virgin coconut oil. Foot care ,foot ankle exercise and foot massage will be demonstrated The samples   will be asked to do return demonstration and correction will be given on timely manner

Behavioural intervention & Demonstration -total 2 hrs (1/2 hr/session- 4 weeks)

Reinforcement-I( 1 hr/week-   8 week   Reinforcement-II (1 hr/week  -8 weeks)

Post test I at  6months

 

Phase II- Voice call Coaching

The participants  will be offered 10- to 20-min voice call coaching sessions will be bimonthly for four sessions within first 2 months and  two sessions within last 2 months. The coach ask each patient to create one specific behavior goal related to physical activity, healthy diet, medical adherence, and/or regular blood glucose monitoring to be addressed during the first 3 months of the study. If a patient have more than one behavior change target, the coach will ask he or she  to prioritize the goals and then, together, they address  one subject per coaching session. At the end of each coaching session, the coachee need to discuss the time, and agenda of the next coaching call with the coach. During each voice call coaching session, the participant is reviewed his or her work in the previous 2 weeks with respect to the self-selected behavior goal and action plan, and then create a new goal or modify  existing goals. If a goal is not achieved, the coach help the participant identify and make a plan for overcoming barriers to achieving the goal. Post test I and II will be carried out after  6 months and  10months respectively.

 


 
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